A Phase 3 interventional study of Premixed Bio-ceramic MTA and Calcium hydroxide in Indirect Pulp Capping, sponsored by Cairo University. Not yet recruiting. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.
Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.
Due to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
Drug: Premixed Bio-ceramic MTA
Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
Drug: Calcium hydroxide
Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
Also known as: Neoputty
Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration
Also known as: Dycal, Hydcal
Immediate Postoperative pain
post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.
Time frame: one week
The thickness of newly formed dentin
The thickness of newly formed dentin will be assessed in Mm through Digora software
Time frame: 3,6,9,12 month
Soft tissue pathology
Swelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)
Time frame: 3,6,9,12 month
Radiographic changes
Radiolucency at the periapical or furcation area and Internal or external root resorption will be assessed through a digital periapical intraoral radiograph either present or not ( Binary)
Time frame: 3,6,9,12 month
No study locations are listed for this record.
Plan to share: No — IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Cairo University